Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
1 other identifier
interventional
60
1 country
2
Brief Summary
This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 2, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 19, 2008
May 1, 2008
January 31, 2006
May 16, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
HamD
Secondary Outcomes (1)
MADRS
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years old
- Currently experiencing major depression
You may not qualify if:
- Known sensitivity to ropinirole
- Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators.
- Significant abnormalities observed in screening laboratory evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Duke Universitycollaborator
- GlaxoSmithKlinecollaborator
Study Sites (2)
Stanford University School of Medicine
Stanford, California, 94305, United States
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Stanford, California, 9430, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Debattista
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 2, 2006
Study Start
January 1, 2006
Study Completion
October 1, 2007
Last Updated
May 19, 2008
Record last verified: 2008-05